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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022064
Company: CHATTEM SANOFI

Summary Review

Products on NDA 022064

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
XYZAL	LEVOCETIRIZINE DIHYDROCHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022064

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/25/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022064lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022064s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064_xyzal_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022064s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2019	SUPPL-38	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s038,022157s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022064Orig1s038,022157Orig1s020ltr.pdf
01/11/2019	SUPPL-37	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s037,022157s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022064Orig1s037,022157Orig1019ltr.pdf
04/02/2018	SUPPL-36	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022064s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022064s036ltr.pdf
10/16/2017	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s034ltr.pdf
07/10/2017	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s033,022157s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s033,022157Orig1s016ltr.pdf
11/08/2016	SUPPL-32	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s032_022157s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s032,022157Orig1s015ltr.pdf
02/09/2017	SUPPL-31	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s031,022157s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022064Orig1s031,022157Orig1s014ltr.pdf
06/23/2016	SUPPL-30	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022064Orig1s030,022157Orig1s013ltr.pdf
11/07/2013	SUPPL-28	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022064Orig1s028,022157Orig1s012ltr.pdf
02/14/2014	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
11/20/2012	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
09/06/2012	SUPPL-24	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022064Orig1s024,022157Orig1s008ltr.pdf
03/07/2011	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022064s020,022157s007ltr.pdf
08/21/2009	SUPPL-17	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022064s017,022157s003ltr.pdf
03/31/2008	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s009ltr.pdf
02/01/2008	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022064s005ltr.pdf
10/18/2007	SUPPL-2	Labeling-Container/Carton Labels		Label is not available on this site.

Labels for NDA 022064

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/02/2019	SUPPL-38	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s038,022157s020lbl.pdf
01/11/2019	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022064s037,022157s019lbl.pdf
04/02/2018	SUPPL-36	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022064s036lbl.pdf
10/16/2017	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s034lbl.pdf
07/10/2017	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s033,022157s016lbl.pdf
02/09/2017	SUPPL-31	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022064s031,022157s014lbl.pdf
11/08/2016	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s032_022157s015lbl.pdf
06/23/2016	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022064s030,022157s013lbl.pdf
11/07/2013	SUPPL-28	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022064s028_022157s012lbl.pdf
09/06/2012	SUPPL-24	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022064s024,022157s008lbl.pdf
03/07/2011	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022064s020,022157s007lbl.pdf
08/21/2009	SUPPL-17	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022064s017,022157s003lbl.pdf
03/31/2008	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s009lbl.pdf
02/01/2008	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022064s005lbl.pdf
05/25/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022064lbl.pdf

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